FDA

IACT Health participated in the trials that has led to Achaogen, Inc. announcement that the FDA has accepted the company’s New Drug Application for plazomicin for the treatment of complicated urinary tract infections including pyelonephritis, and bloodstream infections (BSI) due to certain Enterobacteriaceae in patients who have limited or no alternative treatment options.

“The number of confirmed cases of CRE annually in the U.S. is at least 70,000, and is projected to double by 2022,” said Blake Wise, Achaogen’s Chief Executive Officer. “We are excited about plazomicin’s potential to address certain multi-drug resistant gram-negative infections and feel that plazomicin would be a valuable new treatment option for patients with serious bacterial infections, including those due to CRE and ESBL-producing Enterobacteriaceae.”

The NDA is supported by data from both the EPIC and CARE clinical trials which evaluated the safety and efficacy of plazomicin in patients with serious infections caused by gram-negative pathogens, including extended-spectrum beta-lactamase (ESBL) producing and carbapenem-resistant Enterobacteriaceae (CRE). The FDA granted Breakthrough Therapy designation for plazomicin for the treatment of bloodstream infections (BSI) caused by certain Enterobacteriaceae in patients who have limited or no alternative treatment options. Breakthrough Therapy designation was created by the FDA to expedite the development and review of drugs that target serious or life-threatening conditions.

The FDA agency is streamlining how it reviews and approves drugs, tests, and medical devices.

“We are at an inflection point when it comes to the reductionist design process [of trials]” FDA’s Frank Weichold, MD, Ph.D. said. The agency is moving towards a more holistic approach and wants future trials to consider study design and timeline in regards to the objectives and more flexibility.

Weichold envisions a world in which patients willingly and freely share comprehensive health data in a standardized format. As idealistic as it sounds, he said, there was precedent: Some European countries have had a measure of success creating such systems. He also mentioned the OneSource program, an effort to give patient-centered outcomes researchers access to a cloud-based data set while cutting down on duplicate data entry.